Saudi Arabia · Saudi Food and Drug Authority · Generics
Review target
155 working days
official guidance
Legal time limit
-
Not published
Steps
10
17 requirements
Application fee
SAR 40,000
Fee decision 64/32 (2011)
A generic medicine is registered on the basis of bioequivalence with the original brand. The agency validates the file, evaluates it, sets the price, and its Registration Committee decides. The official target is 155 working days, not counting business validation or time the applicant takes to answer. Medicines equivalent to an innovator product in dosage form, strength, route, quality and indications, where the innovator is registered with a stringent regulatory authority.
The official review target is 155 working days (official guidance). Time the applicant takes to answer questions (clock stops) is not counted. Targets are not actual review times.
The evaluation of a generic drug application is SAR 40,000 for Fee decision 64/32 (2011).
1. Apply online and pay the fee; 2. Technical validation; 3. Business validation (10 days); 4. Complete the file (clock stopped); 5. Evaluation and inspection (120 days); 6. Answer questions (clock stopped); 7. Laboratory testing; 8. Pricing (20 days); 9. Registration Committee decision (15 days); 10. Marketing authorization issued.
Outcome: Marketing authorization issued through the SDR system. It is renewed every five years. Valid for 5 years.
Legal basis: Law of Pharmaceutical and Herbal Establishments and Products and its Implementing Regulations; Registration Rules of Pharmaceutical, Herbal and Health Product Manufacturers and their Products
Each box is one step; arrows show the order. Dashed boxes happen only in some cases; the orange arrows go back (for example after questions).
About 190 days end to end with the official step targets, of which up to 90 days are clock stops (time the applicant uses to answer). Targets, not actual times.
In order, with the official target for each step
What the applicant must provide or meet
Targets, not actual review times
| Validationofficial guidance. Business validation target. It is not counted in the total review target. | 10 working days |
| Longest clock stopofficial guidance. Time the applicant has to answer one wave of questions. At most four waves are allowed. | 60 working days |
| Review targetofficial guidance. Official target in working days for agency time only. The clock stops while the agency waits for the applicant. Actual review times can differ. | 155 working days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| Evaluation of a generic drug applicationApplication · Fee decision 64/32 (2011) | SAR 40,000 |
| License renewal, generic drugRenewal · Fee decision 64/32 (2011) | SAR 10,000 |
Not legal or regulatory advice. Check the current official rules before you act. This summary was checked against the official laws, regulations and regulator guidance on October 3, 2026 (40 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.